OCT-Guided Stent Optimization for Short-Duration Dual Antiplatelet Therapy in Stable Angina

NCT07198529 | Recruiting DMC FDA Device

• 2 other identifiers: No.2025GR0393KOR-2023-02
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate whether the use of optical coherence tomography (OCT), an advanced intravascular imaging tool, can improve stent implantation results and make it possible to shorten the duration of dual antiplatelet therapy (DAPT) in patients with stable angina who undergo percutaneous coronary intervention (PCI). PCI with drug-eluting stents is a standard treatment for patients with stable angina, and these patients are usually prescribed DAPT for 6 to 12 months to prevent stent thrombosis and other complications. However, extended use of DAPT increases the risk of bleeding, which can lead to significant medical problems, especially in patients with high bleeding risk. OCT provides detailed, high-resolution images of the coronary arteries and the implanted stents, allowing physicians to optimize stent expansion and positioning. By ensuring that the stent is well-placed and fully expanded, OCT guidance may lower the risk of complications, potentially reducing the need for prolonged DAPT. In this prospective study, patients with stable angina who require stent implantation will be enrolled and treated with OCT-guided PCI followed by a short course of DAPT. Their outcomes will be compared with those managed using conventional strategies. The primary goal of this trial is to determine whether OCT-guided stent optimization can safely support a short-duration DAPT strategy, thereby reducing bleeding risk without compromising protection against ischemic events such as restenosis, myocardial infarction, or stent thrombosis.

Conditions

Stable Angina; Coronary Artery Disease

Keywords

Optical coherence tomography; stable angina; dual antiplatelet therapy; stent optimization; percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• Net Adverse Cardiovascular Events (NACE)

  Composite of cardiac death, non-fatal myocardial infarction, definite/probable stent thrombosis (ARC definition), stroke, repeat coronary revascularization, or clinically significant bleeding defined as BARC types 2, 3, or 5. Analyses will use time-to-first-event; each component will also be summarized separately as secondary outcomes per protocol.

  12 months after the index PCI

Secondary Outcomes (8)

• Major Adverse Cardiovascular Events (MACE)

  12 months after PCI

• All bleeding events

  12 months after the index PCI

• All-cause death

  12 months after the index PCI

• Cardiac death

  12 months after the index PCI

• Myocardial infarction

  12 months after the index PCI

Study Arms (3)

Short DAPT

EXPERIMENTAL

Patients with optimized stent results confirmed by OCT will receive 1 month of dual antiplatelet therapy followed by clopidogrel monotherapy.

Drug: Short DAPT; Device: OCT-guided PCI

Standard DAPT

ACTIVE COMPARATOR

Patients with suboptimal stent results (malapposition, dissection, under-expansion) with high bleeding risk will continue dual antiplatelet therapy for 6 months, according to guideline recommendations.

Drug: Standard DAPT; Device: OCT-guided PCI

Extended DAPT

ACTIVE COMPARATOR

Patients with suboptimal stent results and high ischemic risk, as judged by the operator, will remain on dual antiplatelet therapy for 12 months.

Drug: Extended DAPT; Device: OCT-guided PCI

Interventions

Short DAPT DRUG

Patients receive aspirin and clopidogrel for 1 month after PCI. After 1 month, aspirin is discontinued and clopidogrel monotherapy is continued.

Short DAPT

Standard DAPT DRUG

Patients with high bleeding risk will receive aspirin and clopidogrel for 6 months after PCI (unoptimization confirmed in OCT), followed by single antiplatelet therapy thereafter.

Standard DAPT

Extended DAPT DRUG

Patients (with stet unoptimazation results in OCT imaging) receive aspirin and clopidogrel for 12 months after PCI.

Extended DAPT

OCT-guided PCI DEVICE

All patients undergo percutaneous coronary intervention with mandatory intravascular imaging using optical coherence tomography to assess stent optimization (expansion, apposition, dissection).

Extended DAPT; Short DAPT; Standard DAPT

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who undergo PCI using a cobalt-chromium everolimus-eluting stent (CoCr-EES)
• Diagnosis of stable angina
• Ability and willingness to provide written informed consent approved by the Institutional Review Board (IRB), and to comply with the study protocol and clinical follow-up schedule
• Age ≥ 19 years

You may not qualify if:

• Patients diagnosed with acute coronary syndrome (ACS), including unstable angina or acute myocardial infarction
• Contraindications to antiplatelet therapy or OCT imaging
• Presence of lesions with severe stenosis, heavy calcification, or marked vessel tortuosity that prevent passage of a guidewire or catheter
• Patients with previously implanted coronary stents in the target lesion

Sponsors & Collaborators

• Abbott: collaborator
• Korea University Guro Hospital: lead

Study Sites (1)

Cardiovascular Center, Department of Internal Medicine, Korea University Guro Hospital

Seoul, Gurodong-ro, Guro-gu, 148, South Korea

RECRUITING

MeSH Terms

Conditions

Angina, Stable; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Central Study Contacts

Soohyung Park, MD, PhD

CONTACT

+82-10-3105-3710; shp503@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Interventional Cardiologist

Model Details: This is a prospective, single-center, open-label study with a parallel assignment design. All patients undergo OCT-guided PCI. Based on OCT findings, patients are categorized into two groups: those with optimized stent results receive short-duration DAPT (1 month), while those with suboptimal stent results continue standard DAPT (6-12 months) according to guidelines. Outcomes will be compared between groups.

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 30, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

KR (1)